FUNCTION OF A PESSARY

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 62/814,410, filed March 6, 2019, titled“DEVICES AND METHODS TO OPTIMIZE THE FORM AND FUNCTION OF A PESSARY,” the disclosure of which is incorporated herein by reference in its entirety.

[0002] This application is also related to U.S. Patent Application Serial No. 15/072,119, entitled“Device and Method to Optimize the Form and Function of a Pessary,” filed March 16, 2016, which claims priority to and the benefit of U.S. Provisional Application No. 62/126,744, filed March 2, 2015, each of the disclosures of which are hereby incorporated by reference in its entirety.

BACKGROUND

[0003] Embodiments are described herein that relate to the field of pessaries and other vaginal devices, and devices and methods to design a pessary. Typical pessaries today are vaginal devices, usually made of silicone, and often in the shape of a ring or disk. They are often used as a treatment for pelvic organ prolapse and for stress urinary incontinence, conditions that affect at least 25% of the female population. Pessaries are the non-surgical standard of care for treatment of pelvic organ prolapse and are a common treatment option for stress incontinence. Pessaries are also sometimes used for treatment of pregnancy-related conditions, such as preterm labor, incompetent cervix, and for diagnostic purposes related to symptoms that may be associated with pelvic organ prolapse. Pessaries could also be developed to incorporate additional therapeutic and/or diagnostic functions, such as sensors to measure physiologic parameters including temperature or indicators of ovulation or pre-term labor, modified shape for preventing preterm delivery, or electronic capabilities to stimulate the vaginal wall. The shape, structure and functions of a pessary have remained largely unchanged over time. Problems associated with pessaries are often caused by suboptimal fit resulting in inadequate symptom control, discomfort, bleeding, discharge, vaginal erosions, and difficult removal. Surgery may be the only alternative for a patient who cannot be properly fitted with a pessary. [0004] The previous solutions for determining pessary fit were meant to be as efficient and non-invasive as possible. The most commonly used solution for determining pessary fit was an in-office fitting of fixed sample sizes, in which a clinician fitted sample sizes into the patient and determined the best fit in real time by observation and patient feedback. Another solution was the inflatable pessary that could be inserted by the patient and inflated to optimal size. The inflatable pessary, made of latex and involving a long protruding stem with a valve for filling, is usually used for more severe prolapse, can be uncomfortable and requires daily removal to avoid discharge and erosion.

[0005] Thus, a need exists for improved devices and methods for determining a pessary fit to optimize the form and function of the pessary.

SUMMARY

[0006] Devices and methods are described herein for modeling the interior of a body cavity, such as the interior of a vagina. A device is configured to be inserted into the cavity and the device includes one or more elements that can be inflated (e.g., using a fluid), such that the one or more elements can be used to model the dimensions of the cavity. The data collected using the device can be used to then design and manufacture a device, such as a pessary, that is optimally sized and shaped for a particular patient. For example, the devices described herein can be inserted into a vagina and one or more expandable elements of the device can be actuated to expand within the vagina and conform to the shape of the interior of the vagina. The data from these ascertained dimensions, which may be obtained by scanning a model or by direct measurement, can be used to design and manufacture a pessary or other device to be inserted into the cavity.

[0007] In some embodiments, one or more expandable or inflatable elements can be inflated using a fluid and/or curable material when the device is disposed within the body cavity, such that the expandable elements form a model of the dimensions of the cavity.

[0008] In one such embodiment, the one or more expandable elements is a single expandable balloon. In another embodiment, the one or more expandable elements is a matrix of expandable pistons. In still another embodiment, the one or more expandable elements is a double layer balloon of which an outer layer is expanded with a curable material. [0009] In some embodiments, devices and methods described herein can use one or more sensors. For example, an optical scanner may be used inside an expandable balloon to ascertain dimensions of the expandable balloon after it has conformed to an interior of a cavity (e.g., vagina). In another example, a device can include accelerometers disposed on the outer surface of an expandable balloon to record acceleration data , which can be used to determine a displacement of each accelerometer from an initial position. The accelerometers can record acceleration data as the expandable balloon is inflated and/or as movements or changes occur to the cavity (e.g., as a user changes position).

[0010] In some embodiments, devices described herein can be used to measure an interior of a cavity (e.g., vagina) at various states of straining. For example, measurements can be taken with a subject being in a supine position to measure the cavity with the walls reduced to a non- prolapsed state. Alternatively or additionally, measurements can be taken with a subject being in a standing position and/or with increased (e.g., maximal) straining to generate a model of the cavity’s dimensions in a non-reduced or less-reduced state. Measurements collected can be used to quantify a subject’s pelvic organ prolapse or lack thereof and may be useful for diagnostic purposes and for assessing therapeutic outcomes.

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] FIG. 1A is a side view of a modeling device, according to an embodiment illustrating a balloon matrix before inflation.

[0012] FIG. IB is a side view of the modeling device of FIG. 1 A illustrating the balloon matrix after inflation customized to a patient.

[0013] FIG. 2 shows a close-up, cross-section of the distal end portion of modeling device of FIG. 1A.

[0014] FIG. 3 is a side view of the modeling device of FIG. 1A shown coupled to a schematic overview of an embodiment of a fluid delivery system.

[0015] FIG. 4A is a side view of the modeling device of FIG. 1A and FIG. 4B illustrates an example computational model of a pessary using the modeling device. [0016] FIG. 5 illustrates an example of the modeling device of FIG. 1A after insertion and expansion of the balloon matrix within a vaginal cavity and a full vaginal interior model based on the expanded balloon matrix of the device.

[0017] FIG. 6 shows a shaft of the modeling device of FIG. 1A with support structures.

[0018] FIG. 7 shows a close-up side view of a balloon and support structure.

[0019] FIG. 8 is a side view of the modeling device of FIG. 1A shown coupled to a schematic overview of an embodiment of a fluid delivery system.

[0020] FIG. 9 shows an embodiment of the device with a urethral support balloon.

[0021] FIG. 10 is a side perspective view of a modeling device, according to another embodiment, with a portion of the elastomeric member removed for illustration purposes.

[0022] FIG. 11 is a side perspective view of the modeling device of FIG. 10, illustrating a fluid flow through a portion of the device.

[0023] FIG. 12 is an enlarged view of a proximal end portion of the device of FIG. 10.

[0024] FIG. 13 is a side perspective view of a portion of a modeling device, according to another embodiment, illustrating pistons of the device in an extended configuration.

[0025] FIG. 14 is a side cross-sectional view of a portion of the modeling device of FIG. 13 illustrating fluid flow through a fill line and illustrating pistons of the device in retracted configuration.

[0026] FIG. 15 is a side cross-sectional view of the portion of the modeling device of FIG. 13 illustrating fluid flow through a fill line and within a piston to cause the piston to move to the extended configuration.

[0027] FIG. 16 is a side cross-sectional view of the portion of the modeling device of FIG. 13 illustrating fluid flow in a reverse direction out of the piston and through a fill line to cause the piston to move back to a retracted configuration.

[0028] FIG. 17 is a side view of a modeling device according to another embodiment, shown disposed within a vagina, which shows a double balloon, between whose layers a curable material such as a gel, or fluid with beads, can be instilled to conform to the vaginal cavity. [0029] FIG. 18 is side view of a modeling device according to another embodiment, shown disposed within a body cavity.

[0030] FIG. 19 is a perspective view of a modeling device according to an embodiment, shown in a deflated state.

[0031] FIG. 20 is a perspective view of the modeling device of FIG. 18, shown in an inflated state.

[0032] FIG. 21 is a side view of the modeling device of FIGS. 19 and 20, shown in an inflated state and conforming to an interior of a cavity.

[0033] FIGS. 22A, 22B, and 22C are cross-sectional views of the modeling device of FIG. 21 taken along lines A, B, and C of FIG. 21, respectively.

[0034] FIG. 23 A and 23B are cross-sectional views of the modeling device of FIG. 21, in a deflated state and in an inflated state, respectively, showing displacements of a set of accelerometers.

[0035] FIG. 23C is an example displacement matrix including displacement data determined using a modeling device, according to an embodiment.

[0036] FIG. 24 is a schematic illustration of an example modeling device, according to an embodiment.

[0037] FIG. 25 is a flowchart illustrating an example method of using a modeling device, according to an embodiment.

DETAILED DESCRIPTION

[0038] Devices and methods are described herein for modelling the interior of a body cavity, such as the interior of a vagina, to then design and manufacture a device, such as a pessary, that is optimally sized and shaped for a particular patient. For example, the devices described herein can be inserted into the vagina and one or more expandable elements of the device can be actuated to expand within the vagina and conform to the shape of the interior of the vagina. The model can be scanned and the data used to design and manufacture a pessary or other device to be inserted into the cavity. In some embodiments, one or more expandable elements are disposed on an exterior of the device and can be inflated using a fluid, such that the array of elements expand and model the dimensions of the cavity.

[0039] In one such embodiment, the one or more expandable or inflatable elements is a single conformable balloon that is flexible enough to conform to the entire vaginal cavity. This balloon is filled with the fluid (e.g., water, air, or other suitable medium) until patient comfort is achieved. Coupled to and/or integrated into a surface of the balloon can be an array of accelerometers for recording acceleration data as the balloon inflates and/or changes configuration. The accelerometers can be axially disposed and connected electrically via flexible connections between them that allow for balloon expansion. In some embodiments, the accelerometers can be arranged in multiple radially-arranged arrays, with more or less arrays providing for a desired degree of spatial resolution for generating measurements of the cavity. Acceleration data recorded by the set of accelerometers can be used to calculate a displacement of each accelerometer. The displacements (or data indicative of such displacements) can be used to design and manufacture a pessary or other device to be inserted into the vaginal cavity.

[0040] Each accelerometer can be used in reference to its initial position upon insertion, e.g., against a rigid body or shaft of a modeling device. The balloon may be held against the rigid body, e.g., with vacuum or other suitable mechanisms. When the balloon is inflated, each accelerometer can move and, during this movement, can record acceleration. The acceleration recorded by each accelerometer can be used to calculate, e.g., via a mathematical algorithm involving integration and other functions, the displacement of that accelerometer. In an embodiment, the calculation may be a double integration of acceleration over a period of time, as integrating acceleration over a period of time provides velocity, which integrated again over the period of time provides position In such embodiment, an initial reference position is known and an initial velocity is known (e.g., zero), and such constants can be used to perform the calculation by integration. Alternatively or additionally, other algorithms or functions (e.g., mapping, filtering, etc.) may be used. In some embodiments, the accelerometers may also be used to obtain measurements of a cavity via movements of or changes to the cavity. For example, a subject may move from a supine to a sitting or standing position, changing an interior shape of their vaginal cavity, and the accelerometers positioned within that cavity can further define the shape of the cavity with these movements. [0041] This embodiment of the modeling device may also be employed to measure a vagina at various states of straining. For example, the device can be used to take measurements when the subject/patient is in the supine position to measure the cavity with the vaginal walls reduced to a non-prolapsed state. Alternatively, measurements could also be taken in the standing position and/or with maximal straining in order to also create a model of the individual’s vaginal dimensions in the non-reduced state. As such, this modeling device can be used as a diagnostic tool in evaluating pelvic organ prolapse.

[0042] In another embodiment, the one or more elements is a single conformable balloon that is flexible enough to conform to the entire vaginal cavity. This balloon is filled with the fluid until patient comfort is achieved. Within the balloon is a shaft that facilitates insertion and also includes an array of paired emitters and sensors. Each emitter can emit a beam of light that is reflected against the internal wall of the balloon, and each sensor can receive the reflected beam to determine the distance between the shaft and the internal wall. Thus, the data from each emitter-sensor pair determines the dimensions of the cavity and may then be used for proper fitting of a pessary shape or for other purposes. The resolution of the measurement is determined by the number of arrays present.

[0043] In another embodiment, a modeling device includes a double-layered balloon or Tillable sleeve that can conform to the body cavity (e.g., vagina) and may be filled with a curable material between its layers to create an internal glove or mold of the vaginal cavity. The mold can then be scanned by various means, either while inside the body or externally. The inside reservoir of the inner balloon layer may be filled with a fluid such as water or saline until the cavity is filled without causing discomfort. In some embodiments, the temperature of this fluid may be altered to facilitate the curing of the curable fluid between the inner and outer layers. The curable material may include a liquid and/or a gel, and may be a medical grade polymer that cures readily to a degree that allows for easy removal of the device from the cavity, but retains its shape when removed from the cavity. Alternatively, beads may be used, in addition to the curable material, to fill the space between the double layer balloons to facilitate the filling of the space and the curing process. The curing process may be facilitated by temperature changes or with UV curing or by interaction with the filling beads. A third female condom like balloon made of a medical grade polymer could be used for an additional layer that would make contact with the vaginal walls and contain the double layer Tillable balloon. The inner layer of the double layer balloon may have a shaft attached at its innermost aspect, at or near the vaginal apex for insertion of the modeling device and for ease of removal after curing is complete. The cured sleeve may be removable by first removing the known volume of water/saline from the internal reservoir and then inverting the cured sleeve. When removed from the cavity, it could be reverted to its original shape and refilled, if necessary, with the known quantity of fluid in the internal reservoir.

[0044] The curable sleeve embodiment may also employ a urethral support attachment toward the distal portion of the vaginal mold. A urethral support attachment may be an important addition for the correction or prevention of stress incontinence, and may consist of an inflatable donut shaped balloon with inflatable prongs that would provide periurethral support. This urethral support attachment may be built into the measuring device, or could also be a separate attachment to the device to measure the necessary support to the urethral to prevent involuntary leaking of urine. A curable gel could be injected into this urethral support attachment balloon, or alternatively the fluid injected into this portion of the device may be a simpler fluid such as water or saline, and a known volume of fluid injected would indicate the proper amount of urethral support needed and thus the size and shape of the desired urethral support attachment.

[0045] In the above embodiment, when a curable gel is utilized, it will be enclosed in a durable medical grade sleeve. The gel itself may be medical grade or not depending on the availability of gels with appropriate properties for curing. An additional layer or sheath made of a biocompatible material may also be used as an additional barrier and safety feature, depending on implementation and design failure mode and effect analysis (DFMEA) analysis.

[0046] This embodiment of the modeling device may also be employed to measure a vagina at various states of straining. For example, the device can be used to take measurements when the subject/patient is in the supine position to measure the cavity with the vaginal walls reduced to a non-prolapsed state. Alternatively, measurements could also be taken in the standing position and/or with maximal straining in order to also create a model of the individual’s vaginal dimensions in the non-reduced state. This type of modeling could be used to quantify an individual’s pelvic organ prolapse or lack thereof and may be useful for diagnostic purposes and/or for assessing therapeutic outcomes.

[0047] In another embodiment, the one or more elements is a matrix of cylindrical pistons, each piston being separately inflatable with the fluid. Because each piston is tillable separately, the expansion amount of each piston can be determined by the amount of fluid delivered to the piston (V=7rr ² h, where“r” is the internal radius of the cylinder that fills with fluid, and“h” is the length along the axis of the cylinder that is filled with fluid). The fill volume data and the position of each piston in the matrix thereby determines the approximate dimensions of the measured cavity. The resolution of the system is defined by the size and number of pistons used. A greater number of smaller pistons will provide greater resolution. Pistons may be arranged perpendicular to the main axis of the device and to each other; alternatively the pistons may be arranged perpendicular to the axis of the device and at various angles with respect to each other. Further, the pistons may be arranged in clusters of similar orientations in order to focus on a specific feature of the cavity being measured.

[0048] In another embodiment, the one or more elements is a matrix of balloons, each balloon on the matrix can be individually inflatable. The fill volume of each balloon is controllable by the clinician such that a desired form and fit for the patient can be achieved. The balloon matrix is arranged around a hollow shaft, or a solid shaft properly fitted with built-in flow-channels. The flow channels can hold fill lines for the individual balloons, such that the individual balloons are separately inflatable with a fluid. Because each balloon is tillable separately, and the fluid is incompressible, the radius of each balloon is fully determined by the amount of fluid delivered to the balloon (V=4/3 r ³ ). Therefore, the fill volume data and the position of each balloon in the matrix can determine the dimensions of the pessary. By inflating and deflating individual balloons to suitable volume/pressure, in conjunction with real-time patient feedback, the clinician can determine desired comfort and fit, as well as record data and changes in shape and pressure.

[0049] Further embodiments of a measuring and/or modeling device may include a combination of the embodiments described above. For example, one or more inflatable balloons may be used at the urethra or bladder neck to serve to create support there to correct incontinence, while the piston or gel mold techniques of measuring could be employed for the size and shape of the more proximal vaginal cavity.

[0050] The measurements and models obtained using the modeling devices described herein can be used to facilitate the speedy production and duplication of a personalized or customized pessary. Furthermore, insofar as the device gives the clinician the ability to collect data adaptably and with patient feedback, the device and methods described herein can also serve as a research tool, a clinical tool and/or a diagnostic tool. New pessary designs can be created, and previously created measurements evaluated. Functionality can be added, including reservoirs for medications, including hormones, antibiotics or probiotics, sensors for movement, temperature, pressure, pulse, pH, hormonal milieu, or other data, nerve or muscle stimulators, etc.

[0051] FIG. 24 is a schematic illustration of a modeling device 515, according to embodiments described herein. The modeling device 515 can include a portion that is insertable into a body cavity BC with expandable element(s) that can inflate or expand to conform to the shape of the interior of the body cavity BC (e.g., vaginal cavity). The modeling device 515 in the inflated state can provide data related to an interior of the body cavity BC, which can be used to produce personalized or customized devices such as pessaries.

[0052] As depicted in FIG. 24, the modeling device 515 can include inflatable or expandable element(s) 520, a shaft 537, fluid delivery element(s) 510, and sensor(s) 532. The modeling device 515 can optionally include energy source(s) 554, electrical component s) 542, support structure(s) 534, and a controller 591, as described herein.

[0053] In some embodiments, modeling device 515 can include a single inflatable element 520 (e.g., a single expandable balloon), while in other embodiments, modeling device 515 can include a plurality of inflatable elements 520 (e.g., a plurality of pistons or a plurality of balloons). Each inflatable element 520 can be configured to transition between a first state (e.g., a resting state, vacuum imposed state) that is deflated or contracted and a second state (e.g., an actuated state) that is inflated or expanded, as well as one or more intermediary states between the first and second states.

[0054] In some embodiments, the inflatable element 520 can be transitioned into an expanded state by directing fluid flow into an interior volume of the inflatable element 520. In some embodiments, the fluid can be an incompressible fluid such that the volume of fluid delivered into the inflatable element 520 can be used to determine a displacement or movement of the inflatable element 520 as it expands. Suitable examples of fluids include saline, water, air, and/or other gaseous and/or liquid solutions. In some embodiments, a material (e.g., a curable gel) can be delivered as a fluid into the interior volume of the inflatable element 520 and then be transformed into a solid, e.g., for generating a physical model of an interior of the body cavity BC. When the inflatable element 520 is positioned within the body cavity BC, the inflatable element 520 can inflate or expand until at least a portion of the inflatable element 520 conforms to an interior shape of the body cavity BC. [0055] In embodiments including a plurality of inflatable elements 520, the inflatable elements 520 can be arranged in one or more axially arranged arrays. Each inflatable element can be independently inflated, e.g., by directing fluid via independent channels or conduits into that inflatable element 520. Each inflatable element 520 can be inflated to conform to a local area of the body cavity BC.

[0056] In some embodiments, the inflatable element 520 can include two layers, e.g., an inner layer disposed over the shaft 537 and an outer layer disposed over the inner layer. Each of the two layers can be independently inflated, e.g., using a fluid. For example, the outer layer can be inflated to conform to an interior of the body cavity BC, and the inner layer can be inflated to provide a space for receiving an energy source (e.g., energy source 554). In such embodiments, the energy source 554 can be used to deliver energy (e.g., UV light) for transforming a fluid in the outer layer into a solid to form a physical model that conforms to an interior of the body cavity BC. After transforming the fluid into the solid model, the inner layer can then be deflated to provide space for removing the solid model.

[0057] In some embodiments, one or more inflatable elements 520 (or portions of inflatable elements 520) can be transparent, reflective, radiopaque, etc., e.g., for visualizing a portion of the body cavity BC, capturing measurements of the body cavity BC, and/or protecting nearby structures. For example, the modeling device 515 can optionally include energy source(s) 554 implemented light source(s) that emit light into an interior volume of one or more inflatable elements 520. The one or more inflatable elements 554 can be formed of a material or include an inner surface formed of a material that is reflective or opaque to reflect and/or contain the emitted light within the inflatable element 554.

[0058] The shaft 537 of the modeling device 515 can be coupled to the one or more inflatable element(s) 520. In some embodiments, the shaft 537 can be used to support one or more inflatable element(s) 520. The shaft 537 can be rigid or flexible, depending on design requirements. In some embodiments, the shaft 537 can be an elongate (e.g., cylindrical) structure that defines a longitudinal axis about which the inflatable element(s) 520 are arranged. The shaft 537 can include a distal portion that is sized and shaped for insertion into the body cavity 537 and a proximal end that can be coupled to one or more other components, e.g., actuators, handles, cables, connectors, fluid delivery elements (e.g., fluid ports, channels, valves), power sources, support structures, etc. [0059] In some embodiments, the shaft 537 can define a hollow area (e.g., a hollow length or lumen) for receiving one or more components. In some embodiments, the shaft 537 can define one or more openings for enabling components (e.g., medical instruments, delivery devices, etc.) to be delivered into the body cavity BC through the shaft 537. In some embodiments, the shaft 537 can be formed of transparent material such that it can receive a light source (e.g., energy source 554) within its hollow area and enable that light source to emit light into an area external to the shaft. For example, a light source such as a UV light source can be disposed within the hallow space of the shaft 537 and be used to emit light into an inflatable element 520 surrounding the shaft 537. As another example, energy source(s) 554) and/or sensor(s) 532 can be positioned within the shaft 537 and be used to emit energy (e.g., light) into the interior of inflatable element(s) 520 surrounding the shaft 537 and/or receive measurements from the interior of the inflatable element(s) 520. In some embodiments, the shaft 537 can be used to house and/or support energy source(s) 554 such as heating elements, e.g., for providing comfort to a subject during the modeling procedure.

[0060] In some embodiments, the shaft 537 or a portion of the shaft 537 can be rotatable and/or translatable relative to a proximal portion of the modeling device 515. For example, the shaft 537 can include or support one or more sensor(s) 532 and/or energy source(s) 554 and be rotatable or translatable to position such sensor(s) 532 and/or energy source(s) 554 relative to each other and/or an interior surface of the body cavity BC to obtain measurements of different regions of the body cavity BC.

[0061] In some embodiments, the modeling device 515 includes sensor(s) 532, e.g., for capturing measurements associated with one or more inflatable element(s) 520. The sensor(s) 532 can be disposable within the body cavity BC. The sensor(s) 532 can be coupled to one or more electrical component s) 542 that can be used to delivery power to and/or receive data from the sensor(s) 532. In some embodiments, the electrical component(s) 542 can be configured to operatively couple the sensor(s) 532 to a controller 591 and/or input/output device 592. The electrical component(s) 542 can be, for example, cables, ports, connectors, wires, leads, etc. for coupling to the sensor(s) 532, controller 591, input/output device 592 and/or other external compute devices (e.g., computers, processors, servers, etc.).

[0062] In an embodiment, the sensor(s) 532 can include a set of accelerometers mounted in a specific arrangement on one or more inflatable element(s) 520, such that acceleration data can be recorded during inflation or expansion of the inflatable element(s) 520. In an embodiment, the sensor(s) 532 can include volume sensors configured to measure a volume of fluid delivered into an inflatable element 520. In an embodiment, the sensor(s) 532 can include energy sensors (e.g., light sensors) configured to sense light emitted into and/or reflected by one or more inflatable element(s) 520. In an embodiment, the sensor(s) 532 can include temperature sensor(s), sound sensor(s), etc. and/or any combination of the above sensors. Data collected by the sensor(s) 532 can be receive at the controller 591 and/or sent to an external compute device (e.g.. via input/output device 592) and used to (1) determine displacement and/or other data for reconstructing an interior space of the body cavity BC and/or (2) monitoring a condition of an individual during a modeling procedure.

[0063] In some embodiments, the modeling device 515 can include energy source(s) 554 that are disposable within and/or outside of the body cavity BC (e.g., in a handle or proximal support structure 534 of the modeling device 515). The energy source(s) 554 can be portable energy sources that are used to power one or more other components (e.g., sensor(s) 532, fluid delivery element(s) 510, controller 591, etc.) of the modeling device 515. Additionally or alternatively, the energy source(s) 554 can include light sources, heating elements, etc. that are disposable within the body cavity BC.

[0064] In some embodiments, the modeling device 515 includes a controller 591 that is operatively coupled to one or more other component s) of the device, e.g., to send signals to and/or receive signals from those components. For example, the controller 591 can be coupled to the sensor(s) 532 for controlling the sensor(s) 532 to record measurements and to receive such measurements from the sensor(s) 532. The controller 591 can be coupled to fluid delivery element(s) 510 to control delivery of fluid into inflatable element(s) 520, e.g., by activating a pump and/or opening or closing a valve. The controller 591 can be coupled to energy source(s) 554 to activate them, e.g., to emit energy into an inflatable element 520 and/or body cavity BC. The controller 591 can be operatively coupled to one or more memory and/or remote devices such that data generated and/or received can be stored, transmitted, and /or analyzed to generate a digital reconstruction of the body cavity BC. In some embodiments, the controller 591 can be configured to implement algorithms to calculate displacement (e.g., from accelerometer or volume data) and to generate a reconstruction or model of an interior of the body cavity BC. The controller 591 can be coupled to an input/output device 591, which can include a display or other output for presenting information associated with displacement of components of the modeling device 515 and/or the interior of the body cavity BC to an operator (e.g., a physician, medical technician, etc.). The controller 591 can include or be implemented as a processor, e.g., a microprocessor, a general purpose processor, a Field Programmable Gate Array (FPGA), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and/or the like.

[0065] In some embodiments, the modeling device 515 include fluid delivery element(s) 510 for delivering fluids to and/or removing fluids from other components of the modeling device 515 (e.g., inflatable element(s) 520, shaft 537) and/or an interior of the body cavity BC. For example, the delivery element(s) 510 can deliver fluid to inflate or expand one or more inflatable element(s) 520. As another example, the delivery element(s) 510 can remove fluid from one or more inflatable element(s) 520 to deflate or contract those element(s). As yet another example, the delivery element(s) 510 can be used to deliver fluids into and/or remove fluids from the body cavity BC, e.g., for circulating fluids during a procedure, producing desirable pressurized environments, etc. The delivery element(s) 510 can include, for example, pumps, vacuums, ports, openings, fluid controllers (e.g., valves), tubing, channels, etc.

[0066] FIG. 25 shows a flowchart 700 illustrating an example method associated with operation of a modeling device (e.g., modeling devices 515 and/or any other devices described herein). The method 700 includes inserting a modeling device into a body cavity (e.g., a vaginal cavity), at 701. The method 700 includes inflating or deploying a portion of the device, e.g., to conform to an interior of the body cavity, at 703. In some embodiments, such inflation or deployment can involve initiating fluid delivery (e.g., using fluid delivery element(s) 510) from an external or local fluid source into a volume defined by an inflatable element (e.g., inflatable element(s) 520) to inflate that inflatable element such that it conforms to the interior of the body cavity. The inflation or deployment can be continued until the interior space of the body cavity is occupied without excess pressure (e.g., without causing a subject discomfort).

[0067] The method 700 includes capturing or recording measurement data, at 707. Such recordings can include, for example, (1) a volume of fluid delivered into one or more inflatable elements (e.g., implemented as a plurality of balloons), (2) a degree of deployment of one or more inflatable elements (e.g., implemented as pistons), (3) detected light or energy (e.g., recorded via an optical or light sensor), (4) scanning data (e.g., of a mold), and/or (5) accelerometer data. The method 700 optionally includes deflating or undeploying the modeling device, e.g., by deflating the inflatable elements, at 709. In instances where another set of measurements are required (e.g., with stress incontinence) (711 : YES), then the device can be inflated or deployed and additional measurements can be captured, e.g., with a subject in a different position (e.g., a supine or upright position).

[0068] The method 700 includes generating, based on the measurements, a digital representation of a portion of the interior of the body cavity, at 715. The digital representation can be used to determine proper sizing and shape of a customized device (e.g., a pessary device) be used to create the customized device. In some embodiments, the digital representation can be used for other diagnostic purposes. The modeling device can be removed from the body cavity after performing the measurements, at 717.

[0069] FIGS. 19 and 20 depict an embodiment of a modeling device 615 that can be used to model the interior of a body cavity, such as the interior of a vagina, to then design and manufacture a device, such as a pessary, that is optimally sized and shaped for a particular patient. The modeling device 615 includes an inflatable or expandable element that is transitionable between a first state (e.g., deflated, contracted) and a second state (e.g., expanded, inflated), as depicted in FIGS. 19 and 20, respectively. The modeling device 615 includes a body 635, a fluid conduit 610, an inflatable element in the form of an elastomeric balloon 620, and sensors in the form of accelerometers 632. The accelerometers 632 can be mounted or disposed in a specified arrangement on the outer surface of the balloon 620.

[0070] The balloon 620 can be coupled to the body 635 of the device, e.g., using a clamp 620 positioned over a proximal portion of the balloon 620. In some embodiments, a flange 634 of the balloon can be disposed proximal of the clamp 620. In some embodiments, the clamp 620 can be implemented as a ring, as shown in FIGS. 19 and 20. The clamp 620 can be configured to hold the balloon 620 and to serve as a coupling or connection point between electrical connections 642 coupled to the accelerometers 632 and an electrical cable 655. The electrical cable 655 can be coupled to a compute device (e.g., controller 591 and/or external compute device), which can receive the sensor data, perform calculations, and generate a digital representation of a body cavity, as described above. The accelerometers 632 can be arranged in a series or axially extending arrays, each with a plurality of accelerometers (e.g., three as depicted in FIGS. 19 and 20) , and a plurality of radially arranged arrays, each also with a plurality of accelerometers. While specific numbers of accelerometers 632 are depicted in specific arrangements in FIGS. 19 and 20, it can be appreciated that different numbers and/or arrangements of accelerometers can be used, e.g., to achieve different degrees of resolution, etc. in measurements. For example, additional axial and radial arrays of accelerometers can be present, with accelerometers in one or more arrays being offset from other arrays. The accelerometers can be connected via the electrical connections 642, which can be flexible to enable radial expansion of the balloon 620. The electrical connections 642 can be integrated into (e.g., adhered to) and/or separate from a surface of the balloon 620.

[0071] FIG. 20 depicts the modeling device 615 with the balloon 620 inflated or deployed. In some embodiments, the balloon 620 can be inflated by delivering fluid into a volume defined by the balloon 620 via fluid delivery elements, e.g., including fluid conduit 610 and ports 648. The ports 648 can be disposed on a shaft of the body 635 of the device 615. When the balloon 620 is inflated, the accelerometers 532 form a matrix for measuring displacement within a body cavity. In some embodiments, the accelerometers 632 can record acceleration data over a period of time associated with deployment or inflation of the balloon 620. The acceleration data can be used to determine the displacement of each accelerometer 632. The data from these displacements can be used to design and manufacture a customized device such as a pessary, that is sized and shaped to an interior of the body cavity.

[0072] Each accelerometer 632 can be used in reference to its initial position, e.g., against the body 635 of the device 615. The balloon 620 with accelerometers 632 may be held against the body 635, e.g., with vacuum or other mechanisms. When the balloon 620 is inflated, the accelerometers 632 can move with the surface of the balloon 620 and, during this movement, acceleration can be recorded by the accelerometers 632 and transmitted (e.g., as signals) to a controller or a processor (e.g., controller 591 and/or external compute device). The controller can determine, using an algorithm, a displacement of each or a set of accelerometers 632 using the accelerometer data, e.g., via integration and/or other methods. In an embodiment, the calculation may be a double integration of acceleration with respect to time, as integrating acceleration over a period of time provides velocity, which integrated again over the period of time provides position In such embodiment, an initial reference position is known and an initial velocity is known (e.g., zero), and such constants can be used to perform the calculation by integration. Alternatively or additionally, other algorithms or functions (e.g., mapping, filtering, etc.) may be used. In some embodiments, the accelerometers 632 may be used to obtain measurements of a cavity via movements of or changes to the cavity. For example, a subject may move from a supine to a sitting or standing position, changing an interior shape of their vaginal cavity, and the accelerometers positioned within that cavity can further define the shape of the cavity with these movements. [0073] FIG. 21 depicts a side view of the modeling device 615, in an inflated state and while conforming to a body cavity of a patient (e.g., as indicated by the contours of the balloon 620). As shown, the modeling device 615 includes eight axially arranged arrays, with each axial array including three accelerometers (e.g., Ai, Bi, Ci along the array 1, etc.) that are positioned at three axial locations corresponding to the cross-sections depicted in FIGS. 22A-22C, as indicated by lines A-A, B-B, and C-C.

[0074] In the cross-sectional views depicted in FIGS, 22A, 22B, and 22C, each accelerometer 632 is shown to have displaced from an initial position to an expanded position. While the accelerometers 632 are depicted as being in these axially arranged arrays and radial arranged arrays, it can be appreciated that one or more accelerometers 632 may not be disposed in the arrays during use. Stated differently, one or more accelerometers 632 may not be in a particular axial plane or cross-section and may move axially, depending on a shape of the body cavity. Such movement of the accelerometers can be captured depending on the resolution (e.g., density) of the accelerometers and/or their arrangement.

[0075] FIGS. 23A and 23B depict the accelerometers 632 along the axial plane indicated by the line A-A in FIG. 21, with the balloon 620 being in a deflated or undeployed state (e.g., Ai, A2, ... , etc.) and in an inflated or deployed state (e.g., ... , etc ) _, respectively. The displacement of each accelerometer 632 shown in these views is identified as DAi, DA2, ... , etc _. In this embodiment, the modeling device 615 has eight circumferential or radially arranged sensors at one or more cross-sectional locations. This number of sensors, which is represented as i in FIG. 23C, can be set based on parameters including a size and/or shape of a body cavity, a size of the balloon 620, a type of sensor being used, a type of balloon 620 being used, availability of patient history and/or other related patient data, and/or the like. The number i can be any number that fits within a desired intent of usage or a particular application.

[0076] FIG. 23C shows an example displacement matrix 750 that can be populated with displacement data, e.g., calculated using accelerometer data. The displacements may be absolute or broken down into a special co-ordinate system (e.g., Cartesian, polar). The combination of displacements can provide the expanded shape (e.g., N number of axial sensor rings) assumed by the balloon 620, which in turn can be used to construct the shape of portions of the body cavity. The example displacement matrix 750 can include a set of measurements that can be used to characterize the body cavity as a discrete 3 -dimensional shape. [0077] FIGS. 1A and IB illustrate an embodiment of a modeling device 15 that can be used to model the interior of a body cavity, such as the interior of a vagina, to then design and manufacture a device, such as a pessary, that is optimally sized and shaped for a particular patient. The modeling device 15 includes multiple expandable balloons 20 that are removably attached to a shaft 37. The balloons 20 and a portion of the shaft 27 are insertable into the vagina, and can be used to collectively model the interior structure of the vagina. Each expandable balloon - such as balloons 21, 22, 23, 24, 25 and 26 (collectively and generally referred to as expandable balloons 20) shown in FIG. 2 - is connected to a fill line, such as fill lines 1, 2, 3, 4, 5 and 6 (collectively and generally referred to as fill lines 10), whereby each expandable balloon is inflatable and deflatable via a corresponding fill line. In this embodiment, each expandable balloon 20 is spherical and expands uniformly, and its position on the shaft is known. With the expansion of a single balloon, a desired pressure against the corresponding part of the vaginal wall may be determined. This desired pressure can be determined by any method preferred by the clinician, for instance, by ascertaining what pressure exerted by the balloon volumes adequately support the vaginal walls without causing discomfort. Subjective input from the patient during the fitting assists the clinician in determining optimal pressure/volume of the balloons. Collectively, the expansion of the entire array of balloons 20 may determine the dimensions of a customized pessary.

[0078] The insertable shaft 37 houses the corresponding fill lines 10 and supports the expandable balloons 20 for insertion into the vagina. A distal part of the shaft 37 supports the plurality of expandable balloons 20 and the proximal part serves as a handle. The shaft 37 is preferably rigid, but need not be straight, so long as the positions of the expandable balloons 20 are fixed and known. In the case of a flexible shaft 37, a semi-rigid molding device can be used to“save” the shape of the shaft after insertion, such that the positions of each of the expandable balloons 20 can be determined. The shaft 37 may be constructed of rigid, semi rigid and flexible materials including, but not limited to, stainless steel, plastics and polyurethane.

[0079] In this embodiment, each expandable balloon 20 is removably attached to the shaft 37 at a separate support cup 61. FIG. 7 illustrates a support cup 61 and balloon 28, coupled to the shaft 37, with the balloon 28 shown expanded in dash lines and unexpanded in sold line. As shown in FIG. 7, the support cup 61 is a segment of a sphere or concave shaped, such that the radius of the expanded balloon 28 does not exceed the radius of the support cup 61. This causes the spherical balloon 28 to expand in alignment with the support cup 61, reducing shifting that might alter the position of the balloon 28. The uniform expansion of the balloon 28 coupled with its known position are assumptions upon which the pessary model can be based. FIG. 6 shows shaft 37 and multiple support cups 61 without attached expandable balloons.

[0080] There can be any number of expandable balloons 20, as long as the position of each expandable balloon is fixed and known, and each balloon expands uniformly without losing its shape, which in the embodiment shown in FIGS. 1A-7 is spherical. The balloons 20 are preferably constructed with an elastomeric polymer, but any flexible material may be used. Corresponding shaft openings such as openings 68 (see FIG. 6) are spaced such that the balloons 20 do not overlap when expanding, which may cause them to abut against each other and deform their spherical shapes. In this embodiment, each expandable balloon 20 ranges from 15 to 30 mm in diameter, the shaft is 20 to 25 mm, such that the diameter of the device ranges from 55 to 85 mm in conformity with average pessary sizes today.

[0081] Insofar as the expandable balloons 20 collectively form a balloon matrix that can be used to model the vaginal interior, it follows that the more expandable balloons 20 there are in the matrix, the more“refined” the model. The expandable balloons 20 may be arranged in any configuration as long as their positions are fixed. One or more balloons 20 may not be spherical, so long as the one or more non-spherical balloons expand uniformly such that its dimensions can be correlated to its volume. For example, FIG. 9 illustrates the device 15 with a“saddle” shaped urethral support balloon 27 configured to abut the bladder neck or midurethra, which may be desirable to model a pessary with a urethral support section for supporting the bladder neck or urethra, for the treatment of stress incontinence.

[0082] Each fill line (e.g., 1, 2, 3, 4, 5, 6) can deliver and extract fluid to an expandable balloon (e.g., 21, 22, 23, 24, 25, 26) corresponding to said fill line. For example, as shown in FIG. 2, fill line 1 can deliver and extract fluid to and from balloon 21, fill line 2 can deliver and extract fluid to and from balloon 22, and so on. A fill line may be any compatible fluid (liquid or gas) delivery line, including but not limited to tubes, pipes, ducts, and walls. Each fill line is connected at one end to an expandable balloon and at the other end to a fluid source (not shown) that causes fluid to enter said expandable balloon.

[0083] In the simplest example, a fluid source can be a syringe. For example, FIG. 8 shows fill lines 1, 2 and 3 connected to syringes 51, 52 and 53, respectively. In some embodiments, the fluid source is an electromechanical valve such as a solenoid valve. FIG. 3 illustrates a fluid delivery system 80 operatively coupled to the device 15 that utilizes a solenoid valve manifold 89, in which each valve of the valve manifold is connected to a fill line 10 of the device 15. This embodiment facilitates control by a microcontroller 91, which is connected to and configured to send and receive data to/from a reversible fluid pump 87, a volumetric flowmeter 83 and optionally pressure gauge 84. Reversible fluid pump 87 transfers fluid between a fluid reservoir 85 and the manifold 89 and fill lines 10 via a master line 81. Master line 81 may be of any size and length and the schematic depicted in FIG. 3 serves only to show connections between elements and not relative distances. In this embodiment, reversible fluid pump 87 can be a peristaltic pump, but the system may use any reversible fluid pump known in the art. The reversible fluid pump 87 may be subject to manual or electronic control. If subject to electronic control, as shown in FIG. 3, reversible fluid pump 87 is coupled to microcontroller 91.

[0084] Fluid reservoir 85 receives, stores and is the source of fluid that can be delivered to each expandable balloon 20. The fluid reservoir 85 can be any reservoir including, but not limited to, tanks, drums, bags, etc. The fluid delivery system 80 may comprise more than one fluid reservoir 85. For instance, each fill line 10 could be served by a separate reservoir and fluid pump for transferring fluid between that reservoir and the fill line.

[0085] The fill volume of each individual balloon 20 is measured. In the embodiment depicted in FIG. 3, the fill volume of each balloon 20 is measured by the volumetric flowmeter 83 coupled to the master line 81. An alternative to the flowmeter 83 is a visual volume marking on or in the fluid reservoir 85. For instance, volume lines may be printed on the reservoir 85 or a window of the reservoir 85 to allow a clinician or user to take a visual measurement of the change in fill volume of each balloon 20 as it is adjusted. Thus, the means for determining the fill volume of each balloon 20 can depend on the design of the fluid delivery system of the particular embodiment. For instance, in the simple example in which a syringe is the fluid source (e.g., as shown in FIG. 8), volume markings on the syringe can be the means for determining the fill volume. In another embodiment, markings on an expandable balloon may be a means to determine the fill volume of that balloon.

[0086] As shown in FIG. 3, the device 15 can include a pressure gauge 84 for monitoring pressure in each balloon. Pressure data can enable the clinician to refine the balloon volumes, by monitoring pressure exerted by corresponding balloon volumes that adequately support the vaginal walls without causing patient discomfort. Subjective input from the patient can help determine comfortable fit, and additional applied pressure at particular areas of the vaginal wall may be desirable for therapeutic purposes. For instance, additional pressure around the bladder neck may be desirable to treat urinary incontinence. Where gas is used, a temperature probe is attached to the distal part of the shaft, such that the volume of each balloon can be determined with reference to the ideal gas law.

[0087] A process for measuring the vaginal cavity and modeling a pessary can include inserting a modeling device as described herein into the vagina. The device can include multiple expandable balloons disposed at fixed positions on a shaft of the device. The balloons, concurrently or consecutively, are expanded to a minimal volume such that little to no pressure is required. Then, each of the expandable balloons can be adjustably inflated and deflated to a desired pressure by operating a fluid delivery system to deliver fluid from a fluid source to the expandable balloon via a fill line. The fill volume of at least one of the expandable balloons is then applied to determine at least one dimension of at least one section of a pessary model.

[0088] For example, as shown in FIGS. 4A and 4B, radial dimensions 127, 128, 129 and 130 of a modeled ring pessary 102 can be determined with reference to the fill volume of balloons 27, 28, 29 and 30, respectively. In the simplest example, the at least one dimension can be input into an existing CAD model such as, for example, a model of an existing base case ring pessary 102. The resulting personalized model can be converted into any file format, such as STEP or STL, for manufacturing or 3D printing. In another example implementation, the outside diameter of ring pessary 102 can be determined by the positions of balloons 27 and 28. Thus, the location of balloon“landmarks” and their diameter may be applied to determine the dimensions of the pessary.

[0089] A more generalized explanation of this step is as follows: the volume of each balloon of the multiple balloons comprises a dataset X = (xl, x2, x3, ... xK}, such as the dataset (xl, x2, x3, . . . xl2} corresponding to the labeled balloons in FIG. 5. This dataset is entered into a function that outputs a pessary model, which is essentially a set of rules for making a customized pessary. The size of the dataset may range from the fill volume for a single balloon, to the fill volume for each balloon of the balloon matrix. For instance, FIGS. 4A and 4B depict an example in which a ring pessary is determined by the data of four balloons, whereas FIG. 9 depicts an example in which a ring pessary with a“saddle” shaped urethral support 27 may even be determined by the volume of a single balloon 27. Insofar as the entire balloon matrix may be used to model the entire vaginal cavity, FIG. 5 shows how the volume for each balloon of the balloon matrix fully determines a model of that balloon matrix. A model corresponding to the entire balloon matrix may be desirable where computer aided design software is used to select different shapes, views, cuts, etc... from the model. This type of model may also allow the clinician to experiment with new pessary designs and shapes.

[0090] In an alternative embodiment, the fill volume of each expandable balloon is recorded, and the expandable balloon matrix is removed from the vagina and re-inflated outside of the vagina to the recorded fill volumes, whereby a physical model is created. In some cases or patients, the balloon matrix may even be removed from the vagina without need for deflation. The physical model is then used to create a pessary model. For instance, the physical model may be scanned and the resulting computational model used for further manipulation and/or manufacturing of the pessary shape. In another example, a mold may be taken of all or a part of the physical model, whereby the mold is used to manufacture customized pessaries.

[0091] The device 15 may further include a removable sheath 12 that covers the balloon matrix. The sheath is clean and/or sterile and biocompatible, and can be disposable, such that a new sheath is used and discarded each time the device is inserted into the patient. The sheath 12 is preferably constructed of polyurethane or nitrile, but can be constructed of any hypoallergenic flexible material. The sheath 12 can facilitate insertion and removal, and can also carry a lubricant to assist with the insertion.

[0092] In another embodiment, the sheath 12 can function as part of the modeling mechanism of the device. In addition, the sheath may have additional functionalities when the balloon fill amounts are determined by optical scanning or other image scanning techniques. For instance, the sheath naturally performs smoothing functions that may refine a computer-aided design model, or its surface may have prints and/or coatings that facilitate data collection by one or more optical sensors and/or scanners. Furthermore, prints and/or coatings on the inside of the sheath may facilitate the use of an endoscopic camera that is inserted into the vagina or the shaft of the device for additional data collection from the interior. Other imaging solutions, such as ultrasound, CT scan or MRI, could be used to capture the measurements and convert them to a digital image, from which a pessary shape could be created. These imaging modalities typically require contrast material, which could be deposited directly on the sheath. [0093] In another embodiment, depicted in FIGS. 10-12, a modeling device 115 includes a single conforming balloon 120, instead of a balloon matrix of multiple balloons. The balloon 120 is attached to a shaft 137 such that at least a portion of the shaft 137 is internal to the balloon. The balloon 120 is sealed and fillable with a clear fluid by means of a fluid supply tube 110, to expand the balloon until it conforms to the shape of the vaginal cavity when inserted therein. For example, as shown in FIG. 12, the balloon 120 can be captured between gaskets 116 attached to the handle 113 and a base 117 of the shaft 137 to seal the balloon 120 during inflation. When inserted within the vaginal cavity, using patient feedback, fit and comfort can be optimized.

[0094] The shaft 137 includes a clear cylindrical body that allows transmission of light, and a circuit board with emitter and sensor array 114. By measuring the time of reflection of light emitted from the emitters (as shown in FIG. 10, emitted rays shown at arrow E, and reflected light shown at arrow R), the sensors 114 can accurately measure the dimensions of the vaginal cavity. Other optical based sensors could also be used to measure the expanded vaginal cavity. The resolution of this measurement can be dependent on the number of sensors fitted onto the circuit board: the more sensors the more resolute will the image be after measurement. In a further embodiment of this optical design, there may be a single emitter and sensor 114 that travel on a rotating and advancing module inside the main shaft 137. As the emitter/sensor advance and rotate, the inner surface is scanned and an image of the cavity may be determined. The combination of rotational and advance speed, and the sampling rate determine the resolution of the measurement. In some embodiments, a single ring of emitter/sensors can be used that are advanced along the length of the shaft. Similarly, a length-wise row of emitters/sensors may be rotated to achieve the same measurement result. The interior surface of the balloon may be reflective or include prints and/or coatings that can facilitate the sensor’s collection of reflection data. Using the dimensions of the vaginal cavity that are determined using the device 115, a custom pessary can be modeled.

[0095] In another embodiment depicted in FIGS. 13-16, a device 215 includes inflatable elements in the form of movable pistons 220. Each piston 220 is in iluidic connection with a fluid source (not shown) by means of a fill line 210, which serves to expand the piston. The fluid source may be located at the proximal end of the shaft, (corresponding to the distal portion of the vagina) with valves controlling the delivery of fluid to each fill line. Thus, an array of cylindrical pistons can also determine the dimensions of the cavity with an approximation that is related to the number of pistons available on the device 215. The number of pistons 220 can vary, and depends in part on the physical limitations due to the size of device. The number of pistons 220 that may be positioned on each face can also vary. Further, each piston 220 can have a minimum diameter that can be driven by a combination of maintaining patient comfort, e.g., by not pushing on tissue with a sharp face (too small of a diameter), and practical manufacturing and functional limits for a piston that is very small. Each piston 220 can have an internal fluid volume that is characterized by a radius“r” and a height“h”. The volume may then be calculated using the mathematical formula V= 7ir2h This is the volume of fluid required to fully extend one piston 220 by an amount equal to the height“h”. Since the fluid used to drive the piston 220 would be of the incompressible type, knowing how much volume of fluid is pumped into the piston 220 can determine how much the piston 220 is able to extend. It is therefore possible to store a mapping for all pistons 220 on the device when extended within the vaginal cavity of a patient, and this mapping may then be used to generate the approximate cavity shape to design and manufacture a custom pessary.

[0096] FIG. 17 illustrates another embodiment of a modeling device that can be used to model the interior of a body cavity, such as the interior of a vagina, to then design and manufacture a device, such as a pessary, that is optimally sized and shaped for a particular patient. The modeling device 315 includes an inner balloon 342 and an outer balloon 344 that are coupled together such that a gap 341 is formed between the inner balloon 342 and the outer balloon 344. The inner balloon 342 and/or the outer balloon 344 are coupled to an elongate member 337 that extends within an interior region or volume 345 of the inner balloon 342. The elongate member 347 can include or have coupled thereto, a handle portion 313 that is disposed outside the interior region 345. The inner balloon 342 can be sealed at a proximal end and provide a port 346 that can be used to inject a fluid material into the interior region 345. For example, the port 346 can include a one-way valve to allow for the injection of the fluid and/or can include a sealable closure or cap (not shown). The fluid material (not shown) can be, for example, a water, saline, or other like fluid. The outer balloon 344 can be sealed at a proximal end and provide a port 348 that can be used to inject a quick curing material into the gap 341 defined between the layers of the inner balloon 342 and the outer balloon 344. The quick curing material can be, for example, a quick curing liquid, gel, spray foam, and/or a medical grade polymer, or other suitable material. For example, in some embodiments, a quick curing gel together with expandable beads can be injected into the gap 341 as described in more detail below. The expandable beads can be, for example, any clear plastic or glass parts, either shaped as spheres or of any irregular shape that is mostly sized in a ratio close to 1 : 1 : 1 for length:width:height. The surface of the beads may be textured or be an open cell structure to ease the absorption of adhesive and curing. The adhesive can be either a fast curing single, or two-component type, or UV-reactive for even faster curing. It may also be possible to use fast curing expanding foam.

[0097] As with the inner balloon 342, the port 348 can include a one-way valve to allow for the injection of the fluid and/or can include a sealable closure or cap (not shown).

[0098] In use, the device 315 can be inserted into a body cavity of a patient, such as a vagina, as shown in FIG. 17. The quick-curing material can be injected into the gap 341 between the balloon layers via the port 348, and the fluid material can be injected into the interior region 345 via port 346. The fluid material (e.g., water, saline) can be injected into the interior region 345 of the inner balloon until the interior region 342 is filled without causing discomfort to the patient. As the fluid is filled into the interior region 342, the fluid exerts a force on the walls of the balloons 342 and 344 and the quick-curing material within the gap 341 such that balloons 342 and 344 conform to the interior shape of the body cavity. This creates an internal glove or mold of the body cavity. In some embodiments, the temperature of the fluid material can be altered to facilitate the curing of the curable fluid in the gap 341 between the inner and outer layers of the balloons 342 and 344 as described in more detail below.

[0099] As described above, the curable material may include a liquid, gel, and/or foam, medical grade polymer, etc. that cures readily to a degree that allows for easy removal of the device 315 from the cavity, but retains its shape when removed from the cavity. Alternatively, beads may be used, in addition to the curable material, to facilitate the filling of the gap and the curing process. The curing process may be facilitated by, for example, temperature changes or with UV curing and/or by interaction with the filling beads. A third female condom-like balloon (not shown) made of a medical grade polymer, for example, could be used for an additional layer that would make contact with the vaginal walls and contain the double layer fillable balloons. After the curing process is complete, the device 315 can be removed from the cavity (e.g., vagina) using for example, the handle portion 313 to grip and maneuver the device 315 out of the cavity, for example, by inverting the cured mold. The cured double layer balloons 342, 344 may be removable, for example, by first removing the known volume of water/saline from the internal region 345 and then inverting the cured sleeve. [00100] When removed from the cavity, it could be reverted to its original shape and refilled, if necessary, with the known quantity of fluid in the internal reservoir. The physical model or mold can then be used to create a pessary model. For instance, the physical model may be scanned and the resulting computational model used for further manipulation and/or manufacturing of the pessary shape. In another example, a mold may be taken of all or a part of the physical model, whereby the mold is used to manufacture customized pessaries. The scanning of the device 315, now in the form of a mold of the body cavity, can be performed by various methods, either while still inside the body cavity or after the device 315 has been removed. In some embodiments, the mold or model can be converted into any file format, such as STEP or STL, for manufacturing or 3D printing as previously described.

[00101] FIG. 18 illustrates another embodiment of a modeling device that can be used to model the interior of a body cavity, such as the interior of a vagina, to then design and manufacture a device, such as a pessary, that is optimally sized and shaped for a particular patient. The modeling device 415 includes an inner balloon 442 and an outer balloon 444 that are coupled together such that a gap 441 is formed between the inner balloon 442 and the outer balloon 444. In this embodiment, the inner balloons 442 can be formed with a clear or transparent material to allow for passage of UV light. In this embodiment, the inner balloon 442 is coupled at its proximal end to a body element 447 that is disposed within an interior region 445 defined by the inner balloon 442. The body element 447 can also be formed with a clear or transparent material to allow for passage of UV light as described in more detail below. The clear body element 447 defines an interior region 456 that can removably receive a UV light source 454 as shown in FIG. 18. The outer balloon 444 is coupled at its proximal end to a base structure 443. A quick-curing material can be injected into the gap 441 defined between the inner and outer balloons 442 and 444 through one or more access ports 448 (two ports 448 shown in FIG. 18). The ports 448 can include a one-way valve or sealable cap as described above for the device 315. The curable material can be any of the materials described above for device 315, and in the example shown in FIG. 18, includes beads 449 along with a UV-curable material. As described above, the beads may be a clear acrylic and generally round with possible multiple flat edges and porosity to better attach to the adhesive. The adhesive may be any UV-curable type that is suitable for plastics (in this case acrylic, a very common application). Once the adhesive has been poured around the beads, the exposure to UV-light solidifies the adhesive and bonds it to the beads creating a single structure that corresponds to the internal vaginal shape. [00102] In use, the device 415 can be inserted into a body cavity (e.g., vagina) of a patient, and the UV light source 454 can be inserted into the interior region 445, as shown in FIG. 18. The quick-curing material can be injected into the gap 441 via the ports 448, and pressure P can be applied to the material to cause the beads to expand and change shape within the gap 449 between the balloon layers 442, 444. The curable material can be injected until the gap 449 is sufficiently filled without causing discomfort to the patient. The force exerted on the curable material causes a force on the walls of the outer balloon 444 such that the outer balloon 444 conforms to the interior shape of the body cavity. The UV light can be used to facilitate and speed-up the curing process of the curable material. This creates an internal glove or mold of the body cavity. As with the previous embodiment, a third female condom-like balloon (not shown) made of a medical grade polymer, for example, could be used for an additional layer that would make contact with the body cavity walls and contain the double layer Tillable balloons. After the curing process is complete, the device 415 and UV light 454 can be removed from the cavity (e.g., vagina). The physical model or mold can then be used to create a pessary model as described above for previous embodiments.

[00103] The foregoing embodiments can be implemented as one or more of the following examples:

[00104] Example 1 : A modeling device comprising: a cylindrical shaft having a proximal end and a distal end; an inflatable element mounted on the shaft to extend over at least a portion of a length of the shaft from the proximal end to the distal end, and defining a volume, the inflatable element configured to have a resting state and an actuated state; a first fluid delivery element configured to fluidically couple the volume defined by the inflatable member, to an external reservoir of fluid located towards the proximal end of the shaft; a second fluid delivery element configured to control flow of fluid from the external reservoir via the first fluid delivery element into the volume such that the inflatable element is transitioned away from the resting state and towards the actuated state, the inflatable element configured to continue moving until at least one of (1) being resisted by an opposing force, or (2) reaching the actuated state.

[00105] Example 2: The device of Example 1, wherein the inflatable element is a balloon member that is sealed and having an expandable surface; the surface of the balloon member includes a plurality of accelerometers, each accelerometer from the plurality of accelerometers being mounted at a specified location from a plurality of specific locations along the surface of the balloon member; and the balloon member is configured to undergo expansion from the resting state towards the actuated state such that each accelerometer from the plurality of accelerometers senses a change in acceleration that is associated with the expansion of the balloon member at the specified location of that accelerometer along the surface of the balloon member, the change in acceleration being related to a linear displacement associated with the specific location of that accelerometer and due to the expansion.

[00106] Example 3 : The device of Example 1, wherein the inflatable element is a balloon member having an expandable inner surface that is configured to at least partially reflect light; the shaft has a longitudinal axis and a circumferential axis, and is configured to at least partially permit passage of light, the shaft including a plurality of light emitters, each light emitter from the plurality of light emitters being mounted at a specified location from a plurality of first locations along a longitudinal axis and along a circumferential axis of the shaft, the shaft including a plurality of light sensors, each sensor from the plurality of light sensors being mounted at a specified location from a plurality of second locations along a longitudinal axis and along a circumferential axis of the shaft, each sensor from the plurality of light sensors being associated with an emitter from the plurality of light emitters; the balloon member is configured to undergo expansion from the resting state towards the actuated state such that: each emitter from the plurality of emitters emits light, at a specified first time point; each sensor from the plurality of sensors senses light (1) emitted by the associated emitter from the plurality of emitters, and (2) reflected by a portion of the inner surface of the balloon member, at a specified second time point; and the device is configured to determine, based on the first time point and the second time point, a linear displacement associated with the potion of the inner surface of the balloon member.

[00107] Example 4: The device of Example 1, wherein the inflatable element is a cylindrical piston that is mounted along an axis orthogonal to a longitudinal axis of the shaft, the piston member being configured to undergo expansion from the resting state towards the actuated state upon flow of a fluid volume via the conduit into the volume; and the device is configured to determine, based on the fluid volume, a linear displacement associated with the piston.

[00108] Example 5: The device of Example 1, wherein the inflatable element is a first balloon member that is sealed and having a reversibly expandable surface that is configured to at least partially permit passage of light, the shaft has a hollow central axis along the length of the shaft, and is configured to at least partially permit passage of light, the shaft being further configured to permit introduction of a light source along the hollow central axis; the device further comprising: a second balloon member configured to be mounted over the shaft and over the first balloon member, the second balloon member having an expandable surface, the first balloon member and the second balloon member collectively defining between them a space; the space being configured to be injected with a volume of convertible fluid in a fluidic state; the second balloon member configured to undergo expansion from a relaxed state towards an expanded state based on the injected volume of convertible fluid; the convertible fluid being capable of conversion to an at least partial solidified state from being exposed to light of a specific wavelength emitted by the light source introduced along the hollow central axis of the shaft; and the device being configured to be (1) inserted into a cavity when the first balloon member is at the resting state, (2) conformed with an inner surface of the cavity when the second balloon member undergoes expansion towards the expanded state, and (3) removed from the cavity when the first balloon member is returned to the resting state.

[00109] Example 6: The device of Example 1, wherein the inflatable element is an array of balloon members mounted on the shaft at specified locations along the length of the shaft, and the conduit includes s plurality of conduits with each conduit from the plurality of conduits fluidically coupling one balloon member from the array of balloon members to the external reservoir.

[00110] Example 9: A method, comprising: introducing a modeling device into a cavity of a patient, the modelling device including a shaft; a inflatable element mounted on the shaft and defining a volume, the moveable element configured to have a resting state and an actuated state; a conduit configured to fluidically couple the volume defined by the inflatable element to an external reservoir of fluid; an actuator configured to control flow of fluid from the external reservoir and via the conduit into the volume, initiating the actuator to direct fluid from the external reservoir and into the volume to inflate the inflatable element away from the resting state and towards the actuated state; continuing to inflate the inflatable element until at least one of (1) receiving a signal indicating a resisting force opposing the inflating (e.g., pressure applied by a portion of the body cavity on at least a portion of the inflatable element), or (2) receiving a signal of discomfort from the patient, or (3) at least a portion of the inflatable element reaching the actuated state; and ceasing the flow of fluid to cease the inflation of the inflatable element. [00111] Example 10: The method of Example 9, further comprising: measuring a linear displacement associated with the inflatable element; and obtaining, based on the measuring the linear displacement, a model of at least a portion of at least one of (1) a volume, or (2) a shape of the cavity.

[00112] Example 11 : The method of Example 9,, wherein the modeling device includes a plurality of accelerometers each accelerometer from the plurality of accelerometers being mounted at a specified location from a plurality of specified locations along the surface of the moveable element; and the inflatable element is configured to undergo expansion from the resting state towards the actuated state such that each accelerometer from the plurality of accelerometers senses a change in acceleration that is associated with the expansion of the moveable element at the specified location of that accelerometer along the surface of the moveable element, the change in acceleration being related to a linear displacement associated with the specific location of that accelerometer and due to the expansion; the method further comprising: calculating the linear displacement associated with the plurality of specified locations; determining, based on the linear displacement, an inner contour of the cavity.

[00113] Example 12: The method of Example 9, wherein the inflatable element includes an array of balloons, the volume includes an array of volumes, the conduit includes an array of conduits, and the actuator includes an array of actuators, each balloon from the array of balloons defining a volume from an array of volumes, and each conduit in the array of conduits coupling each volume from the array of volumes to the external fluid source, each actuator controlling the flow of fluid via each conduit from the array of conduits, the method further comprising: measuring a quantity of fluid flowing through each conduit from the array of conduits to each volume from the array of volumes; calculating a set of dimensional measurements associated with an interior shape of the body cavity; and generating, based on the set of dimensional measurements, a digital representation of the interior shape of the body cavity.

[00114] The foregoing description has been presented for purposes of illustration and description, and is not intended to be exhaustive or to limit the invention to the precise form disclosed. The descriptions were selected to explain the principles of the invention and their practical application to enable others skilled in the art to utilize the invention in various embodiments and various modifications as are suited to the particular use contemplated. [00115] While various embodiments have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where schematics and/or embodiments described above indicate certain components arranged in certain orientations or positions, the arrangement of components may be modified. While the embodiments have been particularly shown and described, it will be understood that various changes in form and details may be made. Any portion of the apparatus and/or methods described herein may be combined in any combination, except mutually exclusive combinations. The embodiments described herein can include various combinations and/or sub-combinations of the functions, components, and/or features of the different embodiments described.

[00116] Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.